Back to resultsExternal Device for Erectile Dysfunction (3D-Erect) (3D-Erect)
Primary Purpose
Erectile Dysfunction, Impotentia Erigendi
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D-Erect
Sponsored by
About this trial
This is an interventional device feasibility trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
- having a female partner willing to participate in the study.
Exclusion Criteria:
- not willing to attempt sexual vaginal intercourse with their partner
- inability to wear/operate the external penile device for any reason
Sites / Locations
- Stanford Health Care, Stanford HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D-Erect arm
Arm Description
Participants will be asked to use the 3D-printed penile device during their intercourse with partners.
Outcomes
Primary Outcome Measures
Change in modified International Index of Erectile Dysfunction score
score 0 to 30 with higher score meaning overall better erectile function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04624126
Brief Title
External Device for Erectile Dysfunction (3D-Erect)
Acronym
3D-Erect
Official Title
Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).
Detailed Description
A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Impotentia Erigendi
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D-Erect arm
Arm Type
Experimental
Arm Description
Participants will be asked to use the 3D-printed penile device during their intercourse with partners.
Intervention Type
Device
Intervention Name(s)
3D-Erect
Intervention Description
3D-printed erectile device for intercourse
Primary Outcome Measure Information:
Title
Change in modified International Index of Erectile Dysfunction score
Description
score 0 to 30 with higher score meaning overall better erectile function
Time Frame
baseline and up to 1 month post-baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
having a female partner willing to participate in the study.
Exclusion Criteria:
not willing to attempt sexual vaginal intercourse with their partner
inability to wear/operate the external penile device for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Eisenberg, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care, Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
First Name & Middle Initial & Last Name & Degree
Francesco Del Giudice, MD
First Name & Middle Initial & Last Name & Degree
Tony Chen, MD
First Name & Middle Initial & Last Name & Degree
Alex M Kasman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
External Device for Erectile Dysfunction (3D-Erect)
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